Non-compliance of patients to drug regimens prescribed by their physicians results in excessive healthcare costs estimated to be around $100 billion per year through lost work days, increased cost of medical care, higher complication rates, as well as drug wastage. In addition, non-compliance of drug regimens by patients during clinical trials may result in denial of FDA clearance for otherwise viable drugs. It is estimated that the average non-adherence rates among patients in clinical trials receiving treatment for chronic conditions can be as high as 57%. See, The New England Journal of Medicine in 2005 (Lars Osterberg, M.D. and Terrence Blaschke, M.D., “Drug Therapy: Adherence to Medication”). If a drug fails to achieve approval in part because participants are not taking the study medication, significant money is wasted and drugs that may be useful to patients never gain approval. Non-compliance refers to the failure to take the prescribed dosage at the prescribed time which results in under-medication or over-medication.
Devices, systems and methods for breath-based monitoring medication adherence are known in the art. Examples of such devices, systems and methods can be found, for example, in U.S. Pat. No. 7,820,108, and U.S. Publication Nos. 2014/0294675, 2010/0255598 and 2014/0341983, the contents of which are incorporated herein by reference in their entirety. Despite the success of such methods, there remains a need in the art for improved products, devices, systems and methods for medication adherence monitoring.